MOUNTAIN VIEW, Calif., May 8, 2024 – IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, today announced its financial results for the fiscal quarter ended March 31, 2024 and provided an update on recent developments. "We are pleased to have exceeded our enrollment target of 110 patients in our randomized study of 3 mg/kg of aplitabart plus FOLFIRI and bevacizumab in second line colorectal cancer," said Fred Schwarzer, Chief Executi ...

Financial Performance - Net losses for the three months ended March 31, 2024, were $49.8 million, compared to $59.3 million for the same period in 2023, reflecting a decrease of $9.5 million [131]. - The accumulated deficit as of March 31, 2024, was $871.1 million, indicating significant ongoing losses since inception [131]. - The company reported a net loss of $49.8 million for the three months ended March 31, 2024, compared to a net loss of $59.3 million for the same period in 2023, indicating an improvement of approximately 16% [165][166]. - Interest income for the three months ended March 31, 2024, was $4.0 million, a decrease from $4.2 million in 2023 [153]. - For the three months ended March 31, 2024, net cash used in operating activities was $42.4 million, compared to $51.0 million for the same period in 2023, reflecting a decrease of approximately 17% [165][166]. - Net cash provided by investing activities for the three months ended March 31, 2024, was $8.7 million, a decrease from $69.8 million in the same period of 2023 [167][168]. Expenses - Research and development expenses decreased to $43.8 million for the three months ended March 31, 2024, from $50.9 million in 2023, a reduction of $7.1 million [150]. - General and administrative expenses were $10.5 million for the three months ended March 31, 2024, down from $13.0 million in 2023, a decrease of $2.5 million [152]. - Personnel-related expenses decreased by $4.1 million due to strategic refocusing efforts [159]. Future Outlook - The company expects to incur significant expenses and increasing operating losses for the foreseeable future as it continues its research and development activities [131]. - Future funding requirements may reach up to $361.9 million for development, regulatory, and commercial milestone payments associated with optioned technologies [172]. - The company anticipates that its current cash resources will be sufficient to fund operations for at least one year from the issuance date of the financial statements [157]. - The company may seek additional funding through public or private equity offerings, debt financings, and collaborations, depending on various factors including product development progress and regulatory approvals [158][163]. Collaboration and Revenue - Collaboration revenue was $0.5 million for both the three months ended March 31, 2024, and 2023, attributed to the Sanofi Agreement [149]. - The termination of the oncology collaboration with Sanofi is expected to result in recognizing deferred revenue of $62.2 million in the quarter ending June 30, 2024 [137]. - The company retains worldwide commercial rights to its product candidates, except those developed in partnership with Sanofi [129]. Cash and Assets - As of March 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $293.8 million, with an accumulated deficit of $871.1 million [156]. - Future minimum lease commitments as of March 31, 2024, were $62.1 million for office and laboratory spaces [170]. - The company did not have any off-balance sheet arrangements during the periods presented [173]. Strategic Focus - The company plans to focus on treating colorectal cancer and autoimmune diseases, deprioritizing hematologic oncology clinical development [128].

MOUNTAIN VIEW, Calif., May 07, 2024 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (NASDAQ:IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, today announced that management will participate in a fireside chat at the 2024 RBCCM Global Healthcare Conference on Tuesday, May 14, 2024, at 2:35 p.m. EDT. A live webcast of the event will be available on the "Events and Presentations" page in the "Investors" section of the Company's website at https://investor.igmbio.com/ne ...

Investors might want to bet on IGM Biosciences, Inc. (IGMS) , as it has been recently upgraded to a Zacks Rank #2 (Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.Individual ...

MOUNTAIN VIEW, Calif., April 17, 2024 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (NASDAQ:IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, today announced that the Company's exclusive worldwide collaboration agreement with Sanofi to create and develop IgM agonist antibodies will now focus exclusively on immunology/inflammation targets. IGM will retain global rights to its proprietary technology related to the oncology targets nominated by Sanofi under the collab ...

Financial Performance - Cash and investments as of December 31, 2023, were $337.7 million, down from $427.2 million as of December 31, 2022[12]. - Collaboration revenue for the fourth quarter of 2023 was $0.7 million, compared to $0.4 million in the same quarter of 2022, and for the full year 2023, it was $2.1 million, up from $1.1 million in 2022[12]. - The net loss for the fourth quarter of 2023 was $60.7 million, or a loss of $1.01 per share, compared to a net loss of $52.6 million, or a loss of $1.19 per share, in Q4 2022[12]. - For the full year 2023, the net loss was $246.4 million, or a loss of $4.71 per share, compared to a net loss of $221.1 million, or a loss of $5.32 per share, in 2022[12]. Expenses - Research and Development (R&D) expenses for the fourth quarter of 2023 were $54.2 million, compared to $45.0 million in Q4 2022, and for the full year 2023, R&D expenses totaled $215.5 million, up from $179.3 million in 2022[12]. - General and Administrative (G&A) expenses for the fourth quarter of 2023 were $11.6 million, consistent with Q4 2022, while for the full year 2023, G&A expenses were $50.1 million, slightly up from $49.7 million in 2022[12]. - The company expects full year 2024 GAAP operating expenses to be between $210 million and $220 million, including approximately $40 million in non-cash stock-based compensation[9]. Cash Projections - The company anticipates ending 2024 with approximately $180 million in cash and investments, which is expected to fund operations into the second quarter of 2026[9]. Clinical Trials - Enrollment in the randomized clinical trial of aplitabart in metastatic colorectal cancer is ongoing, with a target of 110 patients[2]. - Two Phase 1b clinical trials of imvotamab in severe systemic lupus erythematosus and severe rheumatoid arthritis have been initiated, with expectations to generate meaningful initial clinical data by the end of 2024[2].

PART I [Business](index=5&type=section&id=Item%201.%20Business) IGM Biosciences is a clinical-stage biotechnology company developing IgM antibodies for cancer and autoimmune diseases, undergoing a strategic refocusing in late 2023 [Overview](index=5&type=section&id=Overview) * IGM Biosciences is a clinical-stage biotechnology company focused on developing IgM antibodies for cancer and autoimmune/inflammatory diseases[15](index=15&type=chunk) * Key product candidates in clinical testing include **Aplitabart** (DR5 agonist), **Imvotamab** (CD20 x CD3 bispecific), and **IGM-2644** (CD38 x CD3 bispecific)[18](index=18&type=chunk) * In December 2023, the company announced a strategic refocusing to prioritize colorectal cancer and autoimmune diseases, while deprioritizing hematologic oncology and its targeted cytokine product candidate[16](index=16&type=chunk) [Our Differentiated Approach and Proprietary Platform](index=6&type=section&id=Our%20Differentiated%20Approach%20and%20Proprietary%20Platform) * The company's platform is based on IgM antibodies, which have **10 binding domains** compared to **2 for traditional IgG antibodies**, potentially resulting in greater binding strength (avidity) to target cells[20](index=20&type=chunk)[22](index=22&type=chunk) * The potential advantages of IgM antibodies include enhanced cross-linking of cell surface receptors, stronger binding to targets, and a greater ability to utilize complement dependent cytotoxicity (CDC) for cell killing[23](index=23&type=chunk) * IGM has developed proprietary methods to overcome historical manufacturing difficulties, create engineered and bispecific IgMs, extend their half-life, and modulate their CDC mechanism[24](index=24&type=chunk)[25](index=25&type=chunk) [Our Development Programs](index=9&type=section&id=Our%20Development%20Programs) * **Aplitabart**, an IgM antibody targeting Death Receptor 5 (DR5), is being evaluated in Phase 1 combination trials for metastatic colorectal cancer to induce apoptosis in cancer cells[30](index=30&type=chunk)[32](index=32&type=chunk) * **Imvotamab**, a CD20 x CD3 bispecific T cell engaging IgM antibody, is in Phase 1b trials for severe systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), with a planned trial for myositis[34](index=34&type=chunk)[39](index=39&type=chunk)[40](index=40&type=chunk) * **IGM-2644**, a CD38 x CD3 bispecific T cell engaging IgM antibody, is planned for a Phase 1 trial in autoimmune diseases, targeting pathogenic plasma cells[41](index=41&type=chunk)[18](index=18&type=chunk) [Third-Party Agreements](index=11&type=section&id=Third-Party%20Agreements) * In March 2022, IGM entered a global collaboration and license agreement with Sanofi to develop IgM antibodies for **three oncology and three immunology targets**[44](index=44&type=chunk) Sanofi Collaboration Financial Terms | Term | Amount/Details | | :--- | :--- | | **Upfront Payment** | $150.0 million (received May 2022) | | **Potential Milestones (Oncology)** | Up to $940.0 million per target | | **Potential Milestones (Immunology)** | Up to $1,065.0 million per target | | **Profit Share (Oncology)** | 50/50 in major markets (US, EU5, UK, Japan) | | **Royalties (Oncology)** | Tiered low double-digit to mid-teen % in other countries | | **Royalties (Immunology)** | Tiered high single-digit to low-teen % globally | * In January 2021, IGM entered an exclusive license agreement with Medivir AB for birinapant, paying **$1.0 million upfront** and a **$1.5 million milestone**, with up to **$348.5 million** in potential future milestones plus tiered royalties[60](index=60&type=chunk) [Manufacturing and Supply](index=15&type=section&id=Manufacturing%20and%20Supply) * The company operates its own cGMP manufacturing facility for clinical trial materials while also relying on third-party contract manufacturers[61](index=61&type=chunk) * The manufacturing process utilizes Chinese hamster ovary (CHO) cells to produce IgM and bispecific IgM antibodies, followed by proprietary harvesting and purification methods[62](index=62&type=chunk) * Each product candidate is manufactured from a master cell bank, stored in two independent locations to mitigate loss risk[65](index=65&type=chunk) [Competition](index=17&type=section&id=Competition) * The company faces intense competition from major pharmaceutical and biotechnology companies with greater financial resources and experience, including **AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Merck, Novartis, Pfizer, and Roche/Genentech**[66](index=66&type=chunk)[67](index=67&type=chunk)[71](index=71&type=chunk) Competitors by Product Candidate Target | Product Candidate | Target | Key Competitors | | :--- | :--- | :--- | | **Aplitabart** | DR5 | AbbVie, Beijing Sunbio Biotech, Boehringer Ingelheim, Daiichi Sankyo, InhibRx | | **Imvotamab** | CD20 | Genmab/AbbVie, Regeneron, Roche/Genentech, Xencor/Janssen | | **IGM-2644** | CD38 | Genmab, Ichnos Glenmark Innovation, Hi-Bio/I-Mab, Janssen, Sanofi, Xencor | [Intellectual Property](index=19&type=section&id=Intellectual%20Property) * As of December 31, 2023, the company's platform and manufacturing patent portfolio includes **15 patent families** with **48 granted patents**, projected to expire between **2034 and 2044**[76](index=76&type=chunk) * The "Modified J Chain" patent family, a core platform component, covers IgM antibodies with a modified J chain for bispecific creation, with granted patents in the U.S., Europe, and China, expiring in **April 2035**[77](index=77&type=chunk) * The product candidate patent portfolio includes **27 families**; **Aplitabart (DR5)** has three patent families expiring in **2036, 2039, and 2041**, while **Imvotamab (CD20xCD3)** has two published families expiring in **2036**[85](index=85&type=chunk)[86](index=86&type=chunk)[89](index=89&type=chunk) [Government Regulation](index=25&type=section&id=Government%20Regulation) * The company's products are subject to extensive regulation by the FDA and other authorities, covering research, development, manufacturing, and marketing[97](index=97&type=chunk) * The U.S. approval process for biologics involves submitting an Investigational New Drug (IND) application, followed by Phase 1, 2, and 3 clinical trials, and finally a Biologics License Application (BLA)[98](index=98&type=chunk)[104](index=104&type=chunk) * The company may utilize expedited FDA programs such as Fast Track, Breakthrough Therapy, and Accelerated Approval to accelerate development and review for qualifying product candidates[110](index=110&type=chunk)[111](index=111&type=chunk)[112](index=112&type=chunk) * Recent healthcare reforms, including the Inflation Reduction Act of 2022 (IRA), introduce measures like government price negotiation for certain Medicare drugs and inflation rebates, potentially impacting future product pricing and profitability[141](index=141&type=chunk) [Employees and Human Capital](index=41&type=section&id=Employees%20and%20Human%20Capital) * As of December 31, 2023, the company had **224 full-time employees**, with **174** engaged in research and development[144](index=144&type=chunk) * In December 2023, the company announced a strategic refocusing that included a workforce reduction of approximately **22%**[144](index=144&type=chunk) [Risk Factors](index=43&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks from early-stage clinical development, novel IgM antibody therapeutics, intense competition, manufacturing complexities, and the need for significant additional funding * All product candidates are in early-stage clinical or preclinical development, and engineered IgM antibodies represent a novel, unproven therapeutic approach[153](index=153&type=chunk)[156](index=156&type=chunk)[159](index=159&type=chunk) * The company faces significant competition from entities with greater resources, and the complex manufacturing of IgM antibodies presents potential production and supply chain difficulties[153](index=153&type=chunk)[190](index=190&type=chunk)[196](index=196&type=chunk) * The company has incurred significant losses since inception, anticipates continued losses, and will require substantial additional funding to finance operations, which may not be available on acceptable terms[153](index=153&type=chunk)[258](index=258&type=chunk) * Commercial success depends on the ability to operate without infringing third-party patents and to obtain, maintain, and enforce the company's own intellectual property rights[153](index=153&type=chunk)[326](index=326&type=chunk)[330](index=330&type=chunk) [Cybersecurity](index=135&type=section&id=Item%201C.%20Cybersecurity) The company integrates cybersecurity risk management into its overall system, with annual assessments, external consultants, 24x7 operations, and oversight by the Audit Committee * The company has integrated cybersecurity risk management into its overall systems, conducting annual risk assessments to identify and manage threats[404](index=404&type=chunk)[405](index=405&type=chunk) * Governance is provided by the Audit Committee of the Board of Directors, with day-to-day management led by the SVP of Group Operations and a Cybersecurity Steering Committee[411](index=411&type=chunk)[412](index=412&type=chunk) * The company utilizes external resources, including an experienced cybersecurity consultant and a **24x7 network and security operations center**, to assist in designing, implementing, and monitoring its safeguards[408](index=408&type=chunk) [Properties](index=137&type=section&id=Item%202.%20Properties) The company leases approximately 114,100 square feet of office, lab, and manufacturing space in California and Pennsylvania, with leases expiring between 2024 and 2032 * The company leases approximately **114,100 square feet** of space in Mountain View, CA, and additional space in Doylestown, PA, with leases expiring between **June 2024 and June 2032**[415](index=415&type=chunk) [Legal Proceedings](index=137&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, though it may be involved in ordinary course business litigation * As of the report date, the company is not a party to any material legal proceedings[416](index=416&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=140&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq under 'IGMS', has never paid dividends, and intends to retain earnings for future growth * The company's common stock trades on the Nasdaq Global Select Market under the symbol "**IGMS**"[420](index=420&type=chunk) * The company has never declared or paid cash dividends and does not anticipate doing so, intending to retain all future earnings for business growth[422](index=422&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=142&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company reported a **net loss of $246.4 million** in 2023, driven by increased R&D expenses, with **$337.7 million** in cash and a **22% workforce reduction** due to strategic refocusing [Results of Operations](index=145&type=section&id=Results%20of%20Operations) Comparison of Operations (2023 vs. 2022) | (in thousands) | 2023 | 2022 | Change (in thousands) | | :--- | :--- | :--- | :--- | | Collaboration revenue | $2,130 | $1,069 | $1,061 | | Research and development | $215,519 | $179,289 | $36,230 | | General and administrative | $50,072 | $49,736 | $336 | | Loss from operations | ($263,461) | ($227,956) | ($35,505) | | Interest income | $17,743 | $7,035 | $10,708 | | **Net loss** | **($246,416)** | **($221,102)** | **($25,314)** | * The **$36.2 million increase** in R&D expenses in 2023 was driven by a **$19.6 million** rise in personnel-related costs, a **$7.5 million** increase in preclinical program expenses, and a **$6.6 million** increase in depreciation and facilities expenses[455](index=455&type=chunk)[457](index=457&type=chunk)[458](index=458&type=chunk)[459](index=459&type=chunk) * Interest income increased by **$10.7 million** to **$17.7 million** in 2023, primarily due to higher yield rates on cash, cash equivalents, and marketable securities[461](index=461&type=chunk) [Liquidity and Capital Resources](index=148&type=section&id=Liquidity%20and%20Capital%20Resources) * As of December 31, 2023, the company had **$337.7 million** in cash, cash equivalents, and marketable securities and an accumulated deficit of **$821.2 million**[464](index=464&type=chunk) * In July 2023, the company completed a public offering and concurrent private placement, raising net proceeds of **$113.5 million**[463](index=463&type=chunk) * Management believes existing cash resources are sufficient to fund planned operations for at least **one year** past the financial statements' issuance date[465](index=465&type=chunk) Summary of Cash Flows (2023 vs. 2022) | (in thousands) | 2023 (in thousands) | 2022 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | ($192,231) | ($5,853) | | Net cash provided by (used in) investing activities | $68,355 | ($225,644) | | Net cash provided by financing activities | $115,068 | $219,382 | [Critical Accounting Policies and Use of Estimates](index=154&type=section&id=Critical%20Accounting%20Policies%20and%20Use%20of%20Estimates) * Key critical accounting policies involve significant management judgment and estimates, particularly in revenue recognition, accrued research and development expenses, and lease accounting[483](index=483&type=chunk)[484](index=484&type=chunk) * For revenue recognition under collaboration agreements, management identifies performance obligations, estimates transaction price (including variable consideration), allocates it based on standalone selling prices, and recognizes revenue over time using a cost-based input method[485](index=485&type=chunk)[486](index=486&type=chunk)[488](index=488&type=chunk) * Accrued R&D expenses are estimated based on the progress of work completed by third-party service providers (CROs and CMOs), requiring judgment on the stage of completion and agreed-upon fees[489](index=489&type=chunk)[490](index=490&type=chunk) [Financial Statements and Supplementary Data](index=156&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The consolidated financial statements for IGM Biosciences, Inc. as of December 31, 2023, received an unqualified opinion, reporting **$423.4 million** in total assets and a **net loss of $246.4 million** [Consolidated Balance Sheets](index=158&type=section&id=Consolidated%20Balance%20Sheets) Consolidated Balance Sheet Data (as of Dec 31) | (in thousands) | 2023 (in thousands) | 2022 (in thousands) | | :--- | :--- | :--- | | Cash, cash equivalents, and marketable securities | $337,677 | $427,162 | | Total assets | $423,411 | $513,499 | | Total liabilities | $220,177 | $226,236 | | Accumulated deficit | ($821,242) | ($574,826) | | Total stockholders' equity | $203,234 | $287,263 | [Consolidated Statements of Operations](index=159&type=section&id=Consolidated%20Statements%20of%20Operations) Consolidated Statement of Operations Data (Year Ended Dec 31) | (in thousands, except per share data) | 2023 (in thousands) | 2022 (in thousands) | 2021 (in thousands) | | :--- | :--- | :--- | :--- | | Collaboration revenue | $2,130 | $1,069 | $— | | Research and development | $215,519 | $179,289 | $127,026 | | General and administrative | $50,072 | $49,736 | $38,297 | | **Net loss** | **($246,416)** | **($221,102)** | **($165,164)** | | **Net loss per share, basic and diluted** | **($4.71)** | **($5.32)** | **($4.93)** | [Consolidated Statements of Cash Flows](index=162&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Consolidated Statement of Cash Flows Data (Year Ended Dec 31) | (in thousands) | 2023 (in thousands) | 2022 (in thousands) | 2021 (in thousands) | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | ($192,231) | ($5,853) | ($124,982) | | Net cash provided by (used in) investing activities | $68,355 | ($225,644) | $15,461 | | Net cash provided by financing activities | $115,068 | $219,382 | $2,476 | [Notes to Consolidated Financial Statements](index=163&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) * **Note 9 (Sanofi Agreement):** The company received a **$150.0 million upfront payment** in May 2022, recognizing collaboration revenue of **$2.1 million** in 2023 and **$1.1 million** in 2022, with **$146.8 million** recorded as deferred revenue as of December 31, 2023[614](index=614&type=chunk)[618](index=618&type=chunk) * **Note 12 (Restructuring Charges):** In connection with the December 2023 Strategic Refocusing and **22% workforce reduction**, the company recognized restructuring charges of **$1.8 million**, primarily related to severance payments[646](index=646&type=chunk)[647](index=647&type=chunk) * **Note 13 (Income Taxes):** As of December 31, 2023, the company had federal and state net operating loss (NOL) carryforwards of approximately **$207.6 million** and **$423.8 million**, respectively, with a full valuation allowance against net deferred tax assets due to cumulative losses[655](index=655&type=chunk)[656](index=656&type=chunk) [Controls and Procedures](index=198&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2023, with no auditor attestation required for the emerging growth company * Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2023[666](index=666&type=chunk) * Management concluded that the company's internal control over financial reporting was effective as of December 31, 2023[668](index=668&type=chunk) * The company is exempt from providing an auditor's attestation report on internal control over financial reporting as it qualifies as an "emerging growth company"[669](index=669&type=chunk) PART III [Directors, Executive Officers, Corporate Governance, Executive Compensation, and Other Matters](index=200&type=section&id=Items%2010-14) Information for Items 10-14, covering governance, compensation, and related matters, is incorporated by reference from the company's definitive 2024 Proxy Statement * Information for Items 10, 11, 12, 13, and 14 is incorporated by reference from the company's definitive Proxy Statement for the 2024 Annual Meeting of Stockholders[674](index=674&type=chunk)[675](index=675&type=chunk)[676](index=676&type=chunk) PART IV [Exhibit and Financial Statement Schedules](index=201&type=section&id=Item%2015.%20Exhibit%20and%20Financial%20Statement%20Schedules) This section lists the financial statements and exhibits filed with the Form 10-K, with schedules omitted where not applicable or included elsewhere * This section lists the financial statements and exhibits filed with the Annual Report on Form 10-K[681](index=681&type=chunk)

PART I. FINANCIAL INFORMATION This section presents the unaudited financial statements, management's analysis of financial condition and operations, market risk disclosures, and internal controls [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) The unaudited financial statements detail a net loss of $185.7 million and a shift to net cash used in operations [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's assets, liabilities, and equity at specific points in time Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | September 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $174,794 | $121,231 | | Marketable securities | $212,197 | $305,931 | | **Total current assets** | **$398,395** | **$438,421** | | **Total assets** | **$474,350** | **$513,499** | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $42,965 | $44,685 | | Deferred revenue, non-current | $142,539 | $146,195 | | **Total liabilities** | **$220,488** | **$226,236** | | Accumulated deficit | ($760,547) | ($574,826) | | **Total stockholders' equity** | **$253,862** | **$287,263** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section details the company's revenues, expenses, and net loss over specific reporting periods Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $509 | $331 | $1,479 | $697 | | Research and development | $54,762 | $48,179 | $161,329 | $134,272 | | General and administrative | $12,507 | $12,664 | $38,492 | $38,117 | | Loss from operations | ($66,760) | ($60,512) | ($198,342) | ($171,692) | | Net loss | ($61,989) | ($58,037) | ($185,721) | ($168,526) | | Net loss per share, basic and diluted | ($1.04) | ($1.32) | ($3.73) | ($4.15) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section outlines the company's cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | ($144,223) | $32,005 | | Net cash provided by (used in) investing activities | $83,048 | ($206,833) | | Net cash provided by financing activities | $114,666 | $218,900 | | **Net increase in cash, cash equivalents, and restricted cash** | **$53,491** | **$44,072** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes provide critical details on liquidity, revenue recognition, equity financing, and stock-based compensation - The company has incurred net operating losses since inception, with an accumulated deficit of **$760.5 million** as of September 30, 2023. However, management believes its existing cash, cash equivalents, and marketable securities of **$387.0 million** are sufficient to fund operating activities for at least one year[33](index=33&type=chunk) - In July 2023, the company completed a public offering and a concurrent private placement, issuing a total of **15,000,000 shares** of common stock (voting and non-voting) at **$8.00 per share**, resulting in total net proceeds of **$113.5 million** after deducting costs[95](index=95&type=chunk)[96](index=96&type=chunk)[164](index=164&type=chunk) - Revenue is recognized from the **$150.0 million** upfront payment received from the Sanofi Agreement in May 2022. For the nine months ended September 30, 2023, the company recognized **$1.5 million** in collaboration revenue. As of September 30, 2023, **$147.5 million** remained as deferred revenue[108](index=108&type=chunk)[112](index=112&type=chunk) Stock-Based Compensation Expense (in thousands) | Category | Three Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | Research and development | $7,391 | $22,078 | | General and administrative | $4,563 | $15,232 | | **Total** | **$11,954** | **$37,310** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses operational performance, financial condition, and liquidity, highlighting increased R&D expenses and capital raises [Overview](index=30&type=section&id=Overview) This section provides a strategic overview of the company's business, product candidates, and financial performance - IGM Biosciences is a clinical-stage biotechnology company focused on developing IgM antibodies for cancer, autoimmune, inflammatory, and infectious diseases. Its key clinical candidates include Aplitabart (DR5), Imvotamab (CD20/CD3), IGM-7354 (IL-15), and IGM-2644 (CD38/CD3)[126](index=126&type=chunk)[130](index=130&type=chunk) - The company has incurred significant net losses, with a net loss of **$185.7 million** for the nine months ended September 30, 2023, and an accumulated deficit of **$760.5 million** as of that date. Operating losses are expected to continue and increase[129](index=129&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) Operating results show an increased net loss of $185.7 million, primarily due to higher research and development expenses Comparison of Results of Operations (in thousands) | Metric | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | Change | | :--- | :--- | :--- | :--- | | Collaboration Revenue | $1,479 | $697 | $782 | | Research and Development | $161,329 | $134,272 | $27,057 | | General and Administrative | $38,492 | $38,117 | $375 | | Loss from Operations | ($198,342) | ($171,692) | ($26,650) | | Net Loss | ($185,721) | ($168,526) | ($17,195) | - R&D expenses for the nine months ended September 30, 2023, increased by **$27.1 million** compared to the same period in 2022. This was primarily due to: - A **$16.7 million** increase in personnel-related expenses from higher headcount - A **$6.3 million** increase in preclinical stage program expenses - A **$5.6 million** increase in depreciation and facilities expenses[153](index=153&type=chunk)[155](index=155&type=chunk)[156](index=156&type=chunk)[157](index=157&type=chunk) - Interest income increased by **$9.8 million** for the nine months ended September 30, 2023, compared to the prior year period, primarily due to increasing yield rates on cash, cash equivalents, and marketable securities[159](index=159&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintains strong liquidity, bolstered by a recent capital raise, despite significant cash usage from operations - As of September 30, 2023, the company held **$387.0 million** in cash, cash equivalents, and marketable securities and believes these resources are sufficient to fund operations for at least one year[161](index=161&type=chunk)[162](index=162&type=chunk) - In July 2023, the company raised net proceeds of **$113.5 million** from a public offering and concurrent private placement, after deducting discounts, commissions, and offering costs[164](index=164&type=chunk) - Net cash used in operating activities was **$144.2 million** for the nine months ended September 30, 2023, compared to net cash provided by operating activities of **$32.0 million** in the same period of 2022. The 2022 period included a **$149.3 million** increase in deferred revenue from the Sanofi agreement[169](index=169&type=chunk)[170](index=170&type=chunk)[171](index=171&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is exempt from providing quantitative and qualitative disclosures about market risk - As a "smaller reporting company," the company is exempt from providing quantitative and qualitative disclosures about market risk pursuant to Item 305 of Regulation S-K[183](index=183&type=chunk) [Item 4. Controls and Procedures](index=42&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of September 30, 2023, with no material changes to internal financial reporting controls - The company's management, including the CEO and CFO, concluded that as of September 30, 2023, the company's disclosure controls and procedures were effective at a reasonable assurance level[184](index=184&type=chunk) - There were no changes in the company's internal control over financial reporting during the quarter ended September 30, 2023, that have materially affected, or are reasonably likely to materially affect, its internal control over financial reporting[185](index=185&type=chunk) PART II. OTHER INFORMATION This section provides additional information including legal proceedings, risk factors, equity sales, and exhibits [Item 1. Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - As of the report date, the company is not a party to any material legal proceedings[188](index=188&type=chunk) [Item 1A. Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) This chapter details extensive risks related to early-stage development, financial needs, third-party dependencies, and intellectual property [Risks Related to Business and Development](index=43&type=section&id=Risks%20Related%20to%20Business%20and%20Development) This section outlines risks in early-stage product development, clinical trials, manufacturing, and the competitive landscape - All product candidates are in preclinical or early-stage clinical development, and the company may never successfully advance them through clinical trials, obtain regulatory approval, or generate product revenue[192](index=192&type=chunk) - The use of engineered IgM antibodies is a novel and unproven therapeutic approach. The FDA has limited experience with this technology, which may increase the complexity and length of the regulatory approval process[195](index=195&type=chunk)[197](index=197&type=chunk) - Manufacturing of IgM antibodies is complex and has encountered difficulties. Supply chain constraints and staffing issues at a CMO previously caused an adjustment to the IND filing date for IGM-7354[227](index=227&type=chunk)[228](index=228&type=chunk) - The company faces significant competition from major pharmaceutical and biotechnology companies with greater financial, manufacturing, and commercial resources[222](index=222&type=chunk) [Risks Related to Financial Position and Need for Additional Capital](index=70&type=section&id=Risks%20Related%20to%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) This section addresses risks associated with the company's history of losses and the ongoing need for substantial additional funding - The company has a history of significant losses, with a net loss of **$185.7 million** for the nine months ended September 30, 2023, and an accumulated deficit of **$760.5 million**. It anticipates continued losses for the foreseeable future[289](index=289&type=chunk) - Substantial additional funding will be required to finance operations. While current cash is expected to last at least one year, future financing may not be available on acceptable terms, or at all[296](index=296&type=chunk)[297](index=297&type=chunk) [Risks Related to Dependence on Third Parties](index=78&type=section&id=Risks%20Related%20to%20Dependence%20on%20Third%20Parties) This section highlights risks stemming from reliance on third-party manufacturers, clinical research organizations, and strategic partners - The company relies on third-party manufacturers for its product candidates. Any failure by these parties to deliver acceptable products could delay or impair clinical trials and commercialization[335](index=335&type=chunk) - The company depends on third parties such as CROs and academic institutions to conduct and oversee clinical trials. Lack of control over these entities could lead to delays, increased costs, or data quality issues[341](index=341&type=chunk)[342](index=342&type=chunk) - Strategic partnerships, such as the one with Sanofi, are important but pose risks, including partners deprioritizing programs, disagreements over development, or termination of the collaboration[351](index=351&type=chunk)[355](index=355&type=chunk) [Risks Related to Intellectual Property](index=85&type=section&id=Risks%20Related%20to%20Intellectual%20Property) This section details risks concerning the company's ability to protect its intellectual property and avoid infringement claims - The company's success depends on its ability to operate without infringing on the patents of third parties, and it may be subject to costly infringement claims[357](index=357&type=chunk)[358](index=358&type=chunk) - The company's ability to obtain, maintain, and enforce patent and trade secret protection for its technology is uncertain and critical to its business. Patents may be challenged, invalidated, or circumvented[362](index=362&type=chunk)[365](index=365&type=chunk) - The company in-licenses critical technology, such as birinapant from Medivir. Failure to comply with license obligations could result in the loss of necessary intellectual property rights[368](index=368&type=chunk) [Risks Related to Ownership of Our Securities](index=98&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Securities) This section discusses risks associated with the volatility of the company's stock price and the concentrated ownership structure - The market price of the company's common stock may be highly volatile due to factors such as clinical trial results, regulatory developments, and market conditions[409](index=409&type=chunk) - A concentrated group of stockholders, including Topsøe Holding A/S, beneficially owns a majority of the outstanding capital stock, enabling them to control most matters requiring stockholder approval[413](index=413&type=chunk) - The dual-class structure of voting and non-voting common stock may limit the ability of common stockholders to influence corporate matters[416](index=416&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=109&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable for the reporting period - Not applicable[442](index=442&type=chunk) [Item 3. Defaults Upon Senior Securities](index=109&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[443](index=443&type=chunk) [Item 4. Mine Safety Disclosures](index=109&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - None[443](index=443&type=chunk) [Item 5. Other Information](index=109&type=section&id=Item%205.%20Other%20Information) The company reports no other information for this period - None[444](index=444&type=chunk) [Item 6. Exhibits](index=110&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents and officer certifications - Lists exhibits filed with the report, including corporate governance documents and officer certifications required by the Sarbanes-Oxley Act[446](index=446&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39045 IGM Biosciences, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 77-0349194 (State or other jurisdict ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39045 IGM Biosciences, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 77-0349194 (State or other jurisdic ...